NCT03248414已完成不适用
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Fat mass change in 12-week
研究概览
简要总结
In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.
详细描述
We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blinded
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 20-65 years
- •BMI equal to higher than 25 kg/m2
排除标准
- •under anti-obesity medication
- •uncontrolled diabetes
- •uncontrolled hypertension
- •any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics
- •thyroid function test abnormality
- •malignancy within 5 years
- •immune compromised hosts or under immune suppressants
- •antibiotics or probiotics withing 2 weeks
- •any intervention to reduce body weight within 6 months
研究组 & 干预措施
Control
Placebo Comparator
2 packs per day
干预措施: Lactobacillus sakei (Dietary Supplement)
Lactobacillus sakei
Experimental
2 packs per day
干预措施: Lactobacillus sakei (Dietary Supplement)
结局指标
主要结局
Fat mass change in 12-week
时间窗: 12 weeks
fat mass is measured by DEXA
次要结局
- Changes in body weight(12 weeks)
- Changes in waist circumference(12 weeks)
- Glucose metabolism(12 weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital
研究点 (2)
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